EMA releases advice on human immunoglobulin medicine manufacture
The advice lays down what information must be documented during marketing authorisation applications for these medicines
Revised guidance on clinical investigations of human normal immunoglobulin for subcutaneous and intramuscular administrations has been released by the European Medicines Agency (EMA). The advice lays down what information must be documented during marketing authorisation applications for these medicines. The guidance covers biological data, clinical trials and patient follow-up issues, but not quality concerns. The EMA guidance also advises pharmaceutical companies on declarations regarding previously authorised products where a significant change in their manufacturing process has been made.
The paper said that additional data in marketing applications may be needed to support planned pharmacodynamic and therapeutic activities as well as the safety profile of subcutaneous medicines. For example, when considering immunomodulatory and anti-inflammatory treatments for auto-immune diseases, regulators may require information on a medicine’s ability to inhibit auto-antibody activity in vitro; and on experimental autoimmune models.
It said efficacy should be confirmed in open-label, uncontrolled clinical trials of one year's duration in primary immunodeficiency syndromes. At least 40 patients should be included; approximately half should be children and adolescents. Patients should also be monitored over 12 months to avoid seasonal bias.
The guidance stresses that plasma-derived product manufacturers must optimise viral safety through donor selection, screening individual donations and plasma pools for specific infection markers, and inactivating plus removing viruses during manufacturing.